UMIN-CTR Clinical Trial

Basic information
Public title	Effects of navigation system for rehabilitation using digital mirror device in physical activities in patients with dialysis
Acronym	Effects of navigation system for rehabilitation using digital mirror device in physical activities in patients with dialysis
Scientific Title	Effects of navigation system for rehabilitation using digital mirror device in physical activities in patients with dialysis
Scientific Title:Acronym	Effects of navigation system for rehabilitation using digital mirror device in physical activities in patients with dialysis
Region	Japan

Condition
Condition	hemodialysis patients
Classification by specialty	Nephrology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	improvement of the physical activity and abilities and the trunk imbalance, the activities of dairy living
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	the activities of daily living
Key secondary outcomes	standing and sitting postures and trunk balance, mortality, the physical activity, acute myocardial infarction, PTCA and PTA, CHF require hospital care, cerebrovascular event require hospital care, pneumonia, malignancy, bone fracture and event of fall

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Rehabilitation for 15 minutes using digital mirror device
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	patients receiving hemodialysis or peritoneal dialysis
Key exclusion criteria	1.patients who has difficulty in going to hospital 2.patients who judged that a doctor was inappropriate 3.patients who receives exercise function rehabilitation now
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Chieko Middle name Last name Hamada
Organization	Juntendo University Hospital
Division name	Nephrology
Zip code	113-8431
Address	2-1-1 Hongo, Bunkyo-ku, Tokyo, JAPAN
TEL	03-5802-1065
Email	chieko@juntendo.ac.jp

Public contact
Name of contact person	1st name Nao Middle name Last name Nohara
Organization	Juntendo University Hospital
Division name	Nephrology
Zip code	113-8431
Address	3-1-3 Hongo, Bunkyo-ku, Tokyo, JAPAN
TEL	03-3813-3111
Homepage URL
Email	nozaki-n@juntendo.ac.jp

Sponsor
Institute	Ministry of Education, Culture, Sports, Science and Technology
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Juntendo University Hospital
Address	2-1-1 Hongo, Bunkyo-ku, Tokyo, JAPAN
Tel	0338309609
Email	nozaki-n@juntendo.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 09 Month 26 Day
Date of IRB
Anticipated trial start date	2016 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 09 Month 28 Day
Last modified on	2022 Year 10 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027866